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Regulatory Affairs Certificate Program

Comprehensive training on current regulations and their practical application

This certificate program will provide the fundamental skills you need to do your job. Topics include but are not limited to:

  • US regulatory affairs: the IND and NDA and postmarketing
  • European regulatory requirements
  • Preparing for FDA meetings
  • Post-approval regulatory requirements
  • Regulatory requirements for product labeling & advertising
  • Electronic submissions
  • Quality assurance
  • Biosimilars
  • Biologic products
  • Drug development

Certificate Program Requirements

To successfully complete the certificate program, learners must complete 28 Core units and 16 Elective units; courses included in this program are noted below:

Course Name CE Hours Program Units
Adverse Event Reporting Requirements: IND and Post-marketing



Location - Online
None Available 3 Elective Units
Art of Writing a Clinical Overview



Location - Online and Face-to-face
None Available 4 Elective Units
Basics of the IND



Location - Online
None Available 6 Core Units
Basics of the NDA



Location - Online
None Available 6 Core Units
Development of a Clinical Study Report



Location - Online and Face-to-face
None Available 4 Elective Units
Electronic Submissions: The Next Era of Electronic Submissions



Location - Face-to-face
None Available 4 Elective Units
European Regulatory Affairs: Keeping your Finger on the Pulse of Marketing Authorizations



Location - Face-to-face
None Available 6 Core Units
Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets



Location - Face-to-face
None Available 8 Elective Units
How to Prepare for a Safety Inspection



Location - Online
None Available 4 Elective Units
Interactions with the FDA during the IND/NDA Phases



Location - Online
None Available 2 Core Units
Key Considerations for the Development and Marketing of Biosimilar Products



Location - Face-to-face
None Available 8 Elective Units
Navigating Chemistry, Manufacturing and Controls Through the Drug Development Process



Location - Face-to-face
None Available 8 Elective Units
Oversight of Clinical Monitoring: Trends and Strategies None Available 3 Elective Units
Overview of Drug Development in Japan



Location - Online
None Available 6 Elective Units
Preparing for a US FDA Advisory Committee Meeting



Location - Face-to-face
None Available 4 Core Units
Regulatory Affairs for Biologics



Location - Face-to-face
None Available 8 Core Units
Regulatory Affairs: The IND, NDA and Postmarketing



Location - Face-to-face
None Available 16 Core Units
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling



Location - Online
None Available 2 Core Units
Strategies for Good Clinical Practice Audits



Location - Online
None Available 4 Elective Units
Supplements and Other Changes to an Approved Application



Location - Online
None Available 1 Elective Unit